Debunking The Mythologies of Medicinal Cannabis
Associate Professor David Caldicott, B.Sc.(Hons), FRCEM, Dip Med Tox,
Emergency Consultant, Australian National University / University of Canberra
australian medical cannabis observatory
Disclosures…
• Member of ACT Medical Cannabis Advisory Committee
• Provide bipartisan advice at State/Territory & Federal jurisdictions
• Provide pro bono medical advice to Lucy Haslam’s “United in Compassion”
australian medical cannabis observatory
australian medical cannabis observatory
Disclosures…
• Never received a donation, stipend, etc. from either the manufacturers of opiates, or cannabis medication
• I am not a consumer of cannabis, either recreational or medicinal
• I have taken the time to specifically study both recreational, and medicinal cannabis
australian medical cannabis observatory
• Member, Society of Cannabis Clinicians • International Association for Cannabinoid Medicines • completed training for NYSDOH Prescribers Course
I’m a fairly simple man…
australian medical cannabis observatory
Gamekeeper turned poacher…
australian medical cannabis observatory
Beginnings…
australian medical cannabis observatory
Gamekeeper turned poacher…
No apologist for cannabis…
australian medical cannabis observatory
What do we know for sure…?
• >85% support for medicinal cannabis in community
• Roughly 100,000 Australians are already using illicit cannabis for medicinal purpose
• Far, far easier to source through illicit market market than through TGA
australian medical cannabis observatory
What do we know for sure…?
• Huge overseas experience…
>200,000 officially approved patients >30,000 officially approved patients
Family practitioners considered as proper doctors
(#NotJustAGP)
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Current as of 2017
What do we know for sure…?
• In Australia…
What do we know for sure…?
• In Australia…not so much
153 Patients under Special Access Scheme 101 Patients via around 30 Authorized Prescribers
What mythologies are out there?
• “There is no evidence”
• “It’s dangerous”
• “You can’t dose botanical products”
• “Opposition is purely scientific / medical”
australian medical cannabis observatory
How do we decide treatment policy? Individual RCT
Indirect Comparison
Systematic Reviews Of Evidence
Population risk Australian
Epidemiological Evidence
Absolute risk
(Control Rx)
× Tx effect
Associated Resource
use, cost and utility
Policy decisions Net clinical benefit
Net benefit
= Absolute effect difference
Size of effects - benefits & harms (e.g. side effects)
Relative Treatment
Effect
“There’s no evidence”
• Why don’t we have more compelling, contemporary evidence than we seem to for the therapeutic use of cannabis? “As the National Institute on Drug Abuse, our focus is primarily on the negative consequences of marijuana use. We generally do not fund research focused on the potential beneficial medical effects of marijuana.” Shirley Simson, NIDA New York Times, 2010
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Medical Condition # of favourable trials # of unfavourable trials
Chemotherapy-induced nausea and vomiting
Chronic neuropathic pain
Other chronic pain (cancer, rheumatism, fibromyalgia)
Spasticity resulting from disseminated sclerosis
HIV/AIDS-related cachexia none
Cancer-related cachexia
From Grotenhermen F, Müller-Vahl K. The therapeutic potential of cannabis and cannabinoids. Dtsch Arztebl Int 2012; 109: 495-501.
(Referenced by the Australian Medical Association in their assessment against medical cannabis, 2014)
australian medical cannabis observatory
australian medical cannabis observatory
Bunch of Nobodies… • MARIE C. McCORMICK (Chair), Sumner and Esther Feldberg Professor, Harvard T.H. Chan School of Public Health, Harvard University, Boston, MA
• DONALD I. ABRAMS, Professor of Clinical Medicine, University of California, San Francisco, and Chief of Hematology–Oncology Division, Zuckerberg San Francisco General Hospital, San Francisco
• MARGARITA ALEGRÍA, Professor, Departments of Medicine and Psychiatry, Harvard Medical School, and Chief, Disparities Research Unit, Massachusetts General Hospital, Boston
• WILLIAM CHECKLEY, Associate Professor of Medicine, International Health, and Biostatistics, Division of Pulmonary and Critical Care, Johns Hopkins University, Baltimore, MD
• R. LORRAINE COLLINS, Associate Dean for Research, School of Public Health and Health Professions and Professor, Department of Community Health and Health Behavior, State University of New York at Buffalo–South Campus
• ZIVA D. COOPER, Associate Professor of Clinical Neurobiology, Department of Psychiatry, Columbia University Medical Center, New York
• ADRE J. dU PLESSIS, Director, Fetal Medicine Institute; Division Chief of Fetal and Transitional Medicine; and Director, Fetal Brain Program, Children’s National Health System, Washington, DC
• SARAH FELDSTEIN EWING, Professor, Department of Child and Adolescent Psychiatry, Oregon Health & Science University, Portland
• SEAN HENNESSY, Professor of Epidemiology and Professor of Systems Pharmacology and Translational Therapeutics, University of Pennsylvania Perelman School of Medicine, Philadelphia
• KENT HUTCHISON, Professor, Department of Psychology and Neuroscience and Director of Clinical Training, University of Colorado Boulder
• NORBERT E. KAMINSKI, Professor, Pharmacology and Toxicology, and Director, Institute for Integrative Toxicology, Michigan State University, East Lansing
• SACHIN PATEL, Associate Professor of Psychiatry and Behavioral Sciences, and of Molecular Physiology and Biophysics, and Director of the Division of Addiction Psychiatry, Vanderbilt University Medical Center, Nashville, TN
• DANIELE PIOMELLI, Professor, Anatomy and Neurobiology, School of Medicine and Louise Turner Arnold Chair in Neurosciences, Department of Anatomy and Neurobiology, University of California, Irvine
• STEPHEN SIDNEY, Director of Research Clinics, Division of Research, Kaiser Permanente Northern California, Oakland
• ROBERT B. WALLACE, Irene Ensminger Stecher Professor of Epidemiology and Internal Medicine, Department of Epidemiology, University of Iowa Colleges of Public Health and Medicine, Iowa City
• JOHN WILEY WILLIAMS, Professor of Medicine, Duke University Medical Center, Durham, NC
australian medical cannabis observatory
australian medical cannabis observatory
australian medical cannabis observatory
Where’s the evidence?
• Prescribing Practice
australian medical cannabis observatory
Bradford AC, Bradford WD. Medical Marijuana Laws Reduce Prescription Medication Use In Medicare Part D. Health Aff (Millwood). 2016 Jul 1;35(7):1230-6.
Where’s the evidence?
Where’s the evidence?
• Prescribing Practice
• “found no changes after implementation of a medical marijuana law in the number of daily doses filled in condition categories with no medical marijuana indication”
• “provides strong evidence that the observed shifts in prescribing patterns were in fact due to the passage of the medical marijuana laws.”
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• Total estimated Medicaid savings associated with these laws ranged from $260.8 million in 2007 to $475.8 million in 2014
• If all states had legalized medical marijuana in 2014, “The national savings for fee-for-service Medicaid would have been approximately $1.01 billion”
• This works out to an average per state savings of $19.825 million a year
Bradford AC, Bradford WD. Medical Marijuana Laws May Be Associated With A Decline In The Number Of Prescriptions For Medicaid Enrollees. Health Aff (Millwood). 2017 May 1;36(5):945-951.
Where’s the evidence?
Where’s the evidence?
• Epidemiology
australian medical cannabis observatory
Where’s the evidence?
• “states with medical cannabis laws had a 24.8% lower mean annual opioid overdose mortality rate…compared with states without medical cannabis laws.”
• “such laws were associated with a lower rate of overdose mortality that generally strengthened over time,”
• about 1,700 fewer deaths in 2010 alone
Where’s the evidence?
• Why? • patients with chronic non-cancer pain who would have otherwise initiated
opioid analgesics choose medical cannabis instead
• patients already receiving opioid analgesics who start medical cannabis treatment experience improved analgesia and decrease their opioid dose, thus potentially decreasing their dose-dependent risk of overdose
• medical cannabis laws lead to decreases in polypharmacy—particularly with benzodiazepines—in people taking opioid analgesics, overdose risk would be decreased
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Findings…
• Extended Bachhuber et al.’s analysis by including three more years of data.
• also looked at drug treatment admissions related to opioids • less common in states that implemented medical marijuana laws • longer medical marijuana was legally available, the bigger the
apparent benefit.
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“It’s dangerous”
australian medical cannabis observatory
Lachenmeier DW, Rehm J. Comparative risk assessment of alcohol, tobacco, cannabis and other illicit drugs using the margin of exposure approach. Sci Rep. 2015 Jan 30;5:8126.
“You can’t dose a botanical product…”
• Sure, you can…
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“You can’t dose a botanical product…”
• Sure, you can… Type Item THC CBD CBD Rich
T0/C24 CBD Medical Cannabis 0% (0.0% - 0.5%)
24% (20% - 28%)
T1/C20 CBD Medical Cannabis 1% (0.0% - 2.5%)
20% (16% - 24%)
T3/C15 CBD Medical Cannabis 3% (0.5% - 5.5%)
15% (11% - 19%)
T5/C10 CBD Medical Cannabis 5% (2.5% - 7.5%)
10% (6% - 14%)
T10/C10 Medical Cannabis 10% (6% - 14%)
10% (6% - 14%)
THC Rich T10/C2 Sativa Medical Cannabis 10% (6% - 14%)
2% (0.2% - 3.8%)
T10/C2 Indica Medical Cannabis 10% (6% - 14%)
2% (0.2% - 3.8%)
T15/C3 Sativa Medical Cannabis 15% (11% - 19%)
3% (0.5% - 5.5%)
T15/C3 Indica Medical Cannabis 15% (11% - 19%)
3% (0.5% - 5.5%)
T20/C4 Sativa Medical Cannabis 20% (16% - 24%)
4% (1% - 7%)
T20/C4 Indica Medical Cannabis 20% (16% - 24%)
4% (1% - 7%)
australian medical cannabis observatory
“You can’t dose a botanical product…”
• Sure, you can…
Indication Recommended Product for Start of
Treatment
Recommended Gradual E.P. Course for Further Treatment
Chemotherapy, up to 6 months, nausea, vomiting or treatment-associated pain
T10/C2
T10/C10 → T15/C3 →T20/C4
Stage IV cancer pain
T10/C2
T10/C10→T15/C3→T20/C4
Neuropathic pain of a clear organic source
T10/C10
THC-rich products for immediate relief +
CBD-rich products for long-term treatment
AIDS, to improve appetite, relieve vomiting, digestive system symptoms after all accepted medication treatment has been exhausted, who also suffer from severe weight loss (cachexia – more than 10% loss of body weight
T10/C10
T10/C2→T15/C3→T20/C4 australian medical cannabis observatory
A titration protocol (depending on potency) of cannabis products • Start at any of the boxes
• Treatment progresses in any direction of an arrow
• If the next treatment grade causes an undesired response, return to the previous
amount, or to another starting point determined by the physician
CBD RICH THC RICH Cannabis product
T0 C24
T1 C20
T3 C15
T5 C10
T10 C2
T10 C10
T15 C3
T20 C4
Mon
thly
can
nabi
s am
ount
(gra
ms)
20 20 20 20 20 20 20 20
30 30 30 30 30 30 30 30
40 40 40 40 40 40 40 40
50 50 50 50 50 50 50 50
60 60 60 60 60
“You can’t dose a botanical product…”
“You can’t dose a botanical product…”
• Sure, you can…
australian medical cannabis observatory
Who is opposed to medicinal cannabis?
• 3 main groups of opponents…
Those unfamiliar with literature / ?confused with medical vs. recreational
cannabis?
Those who have a moral / political
problem with drug use
Those involved with companies that make opiates or other analgesics
australian medical cannabis observatory
Dr. Herbert Kleber
(OxyContin)
(Zohydro)
Dr. A. Eden Evins Dr. Mark L. Kraus
Who is opposed to medicinal cannabis?
• One other subcategory…
Those involved with companies that would
block use of a ‘botanical’ product
Who is opposed to medicinal cannabis?
australian medical cannabis observatory
• But why would anybody do that? • Because it competes with their own product… • E.g. …
• Sativex (THC:CBD= 1:1) • Made from cannabis • Can make you high • Only one indication • Stunningly expensive
Lu L, Pearce H, Roome C, Shearer J, Lang IA, Stein K. Cost effectiveness of oromucosal cannabis-based medicine (Sativex®) for spasticity in multiple sclerosis. Pharmacoeconomics. 2012 Dec 1;30(12):1157-71.
Who is opposed to medicinal cannabis?
http://www.health.nsw.gov.au/PainManagement/Documents/appendix-1-national-pain-strateg.pdf
The pharmaceutical industry does not just create ‘cures’…
It also creates
customers
Can Medicinal Cannabis Meet 2 Criteria?
• Make your patient feel better?
• Benefits exceed the risks (by a wide margin)?
australian medical cannabis observatory
In Summary…
• “There is no evidence”
• “It’s dangerous”
• “You can’t dose botanical products”
• “Opposition is purely scientific / medical”
australian medical cannabis observatory
In Summary…
• There’s actually quite a lot of evidence, and it’s growing
• “It’s dangerous”
• “You can’t dose botanical products”
• “Opposition is purely scientific / medical”
australian medical cannabis observatory
It’s far less dangerous than many drugs, esp. when use supervised
Of course you can- it’s already being done
Much opposition is political / ideological / commercial
australian medical cannabis observatory
